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OpenTrials
Completed

NCT Number: NCT06095843

"Bony Changes Around Dental Implant in Free Fibular Graft Versus Non-Vascularized Iliac Crest Graft"

The goal of this clinical trial is to evaluate the bony changes around dental implants in non-vascularized iliac crest grafts and free vascularized fibular flap in mandibular reconstruction.

The main question it aims to answer are:

• evaluate the bony changes around dental implants and it's survival rate in both groups

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Key information

Conditions

Crestal Bone Loss Survival Rate

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 00000, Egypt

About this study

The current prospective study was conducted on 10 patients that were selected and admitted for early or delayed mandibular reconstructive surgery from the outpatient who were referred to the department of Oral and Maxillofacial Surgery Faculty of Dentisry, Ain Shams University in the period from January 2018 till June 2022.

The patients in this study were divided into two groups. First group endured non-vascularized iliac crest grafting with delayed implant insertion while the second group endured vascularized fibular flap with delayed implant insertion. Implant placement was done six months after performing reconstructive surgery.At the second stage surgery, all succeeded implants were loaded with fixed implant supported prothesis. Follow- up was done 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.

Crestal bone stability was analyzed using CBCT radiographs along with the percentages of of the survived implants and ISQ values were measured using an ostell device.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients following traumatic injuries
  • gunshot injuries
  • tumor ablative surgeries
  • osteomylitis and osteonecrosis affecting the mandible

Exclusion criteria

  • cardiovascular or pulmonary disease
  • vascular or bone disorder
  • previous fractures or surgeries related to the donor site

Treatment and study plan

placement of dental implants

Procedure

placement of dental implants in mandibular reconstruction.

Primary outcomes

  1. bony changes around dental implants

    Time frame: 1 year

    measuring crestal bone loss (mm)

  2. survival rate of dental implants

    Time frame: 1 year

    measuring survival rate of dental implants (%)

  3. stability of dental implants

    Time frame: 1 year

    measuring primary and secondary stability (ISK)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

"Bony Changes Around Dental Implant Placed in Free Vascularized Fibular Graft Versus Non-Vascularized Iliac Crest Graft in Mandibular Reconstruction"

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2023
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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